Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation

Type 2 Diabetes Clinical Trial

Official title:

Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation in a Chinese Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05370560
• Other study ID #: YR202205
• Status: Completed
• Start date: December 1, 2010
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2022
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective: To investigate the association between plasma transthyretin levels and risk of newly diagnosed type 2 diabetes mellitus (T2DM) and impaired glucose regulation (IGR) in a Chinese population.

Design: We performed a case-control study, including 1,244 newly diagnosed T2DM patients, 837 newly diagnosed IGR patients, and 1,244 individuals with normal glucose tolerance (NGT). The diagnostic criteria were recommended by World Health Organization in 1999. All cases were recruited from patients who, for the first time, received a diagnosis of T2DM in the Department of Endocrinology, Tongji Hospital, Tongji Medical College, Wuhan, China, from December 2010 to December 2016. Concomitantly, general population undergoing a routine health checkup in the same hospital were enrolled as controls. The inclusion criteria were age ≥ 30 years, BMI < 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia. Participants with clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases, were excluded from the present study. Written informed consent was obtained from each participant. Besides, cases were stringently matched to controls in a 1:1 ratio, based on sex and age (± 3 years). All participants enrolled were of Han ethnicity, and gave a commitment of taking no medication known affecting glucose tolerance or insulin secretion before participating in the study. Fasting blood samples were collected in EDTA-anticoagulative tubes and separated for plasma within 1 h. Then plasma was kept at -80℃ prior to analyses. Plasma transthyretin levels were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3325
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 82 Years

Eligibility

Inclusion Criteria:

• Age = 30 years, BMI < 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia

Exclusion Criteria:

• Clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases.

Incomplete basic information.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Impaired Glucose Regulation
• Type 2 Diabetes

Intervention

Other:
• Plasma transthyretin concentration
Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liegang Liu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 2 diabetes mellitus	In the case-control study, type 2 diabetes mellitus was diagnosed in accordance with the diagnostic criteria recommended by WHO in 1999.	From December 2010 to December 2016